SMARTMOUTH  ADVANCE CLINICAL FORMULA- sodium monofluorophosphate paste, dentifrice 
Triumph Pharmaceuticals Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Smart
Mouth™
ADVANCED
CLINICAL FORMULA™
TOOTHPASTE

Drug Facts

Active Ingredient

Sodium monofluorophosphate (0.81%) (0.10% w/v of fluoride ion)

Purpose

Anticavity

Use

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive Ingredients

Sorbitol, Hydrated Silica, Glycerin, Water, Sodium Lauryl Sulfate, Flavor, Titanium Dioxide, Xanthan Gum, Sodium Benzoate, Benzoic Acid, Sodium Saccharin, Zinc Chloride, D&C Yellow #10 and FD&C Blue #1

Questions or comments

1-800-492-7040

SmartMouth™ is a trademark of
and distributed by:
Triumph
Pharmaceuticals Inc.

St. Louis, Missouri 63132
Made in USA ©2011

PRINCIPAL DISPLAY PANEL - 170 g Tube Label

smart
mouth™

PREMIUM
TOOTHPASTE

Clinically Developed By Dentists

Zn+2

Protect

Repair

Clean

MILD FLAVOR / NO AFTERTASTE

ANTI-CAVITY WITH FLUORIDE

REMOVES DENTAL PLAQUE

REMINERALIZES ENAMEL

SENSITIVE WHITENING

GUARANTEED

MILD MINT • NET WT. 6 OZ (170g)

Principal Display Panel - 170 g Tube Label
SMARTMOUTH   ADVANCE CLINICAL FORMULA
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76357-106
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Sorbitol (UNII: 506T60A25R)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
Glycerin (UNII: PDC6A3C0OX)  
Water (UNII: 059QF0KO0R)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Xanthan Gum (UNII: TTV12P4NEE)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Benzoic Acid (UNII: 8SKN0B0MIM)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Zinc Chloride (UNII: 86Q357L16B)  
D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINT (mint vanilla) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76357-106-04170 g in 1 TUBE; Type 0: Not a Combination Product06/17/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35506/17/2011
Labeler - Triumph Pharmaceuticals Inc. (017853461)

Revised: 1/2021
Document Id: 3edc9654-62e0-4c93-8cc7-123cd9edd10c
Set id: 9caa17c9-f864-4c9c-b2ea-dfaed0c6708e
Version: 6
Effective Time: 20210112
 
Triumph Pharmaceuticals Inc.